Brainmaster 2E Module and Software Biofeedback Device

FDA 510(k) K990538 · Brainmaster

Substantially Equivalent

510(k) numberK990538

Submission

Device name
Brainmaster 2E Module and Software Biofeedback Device
Applicant
Brainmaster
Great Neck, NY, US
Received
February 19, 1999
Decision date
May 19, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Brainmaster 2E Module and Software Biofeedback Device cleared by the FDA?

Brainmaster 2E Module and Software Biofeedback Device (K990538) received a 510(k) decision of Substantially Equivalent on May 19, 1999, 89 days after the submission was received.

What is the product code of K990538?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.